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Statins are highly effective for reducing the risk of atherosclerotic cardiovascular disease (ASCVD), even though many patients are reluctant to continue with guideline-directed doses due to muscle-related side effects. A review published Aug. 28 in the Journal of the American College of Cardiology provides definitions of statin intolerance and approaches for optimizing cardiovascular risk reduction in patients with statin-associated muscle complaints.

Robert S. Rosenson, MD, FACC, et al., discuss how the inability to tolerate some statins should not be considered statin intolerance, if it does not prevent achieving treatment thresholds based on the reduction in low-density lipoprotein cholesterol (LDL-C). Patients with muscle symptoms can continue statin therapy and should avoid statin discontinuation – which results in increased ASCVD risk – especially in high-risk patients.

To confirm the presence of statin-associated muscle symptoms (SAMS) in patients, the researchers note it is important to first discontinue the statin and then re-challenge. "The major limitation in the diagnosis and treatment of SAMS is the lack of criteria that distinguishes true SAMS from non–statin-related muscle pain," the researchers write. "A substantial portion of SAMS probably represents nonspecific musculoskeletal pain unrelated to statin use."

After pooling data from 42 large randomized trials with 56,000 patients, no differences were found in muscle symptoms with statins compared with placebo, with 13 percent of participants in each group having reported muscle symptoms.

Patients with low likelihood of SAMS should be evaluated for other diseases affecting the musculoskeletal system, a history of medication-related side effects and psychological factors affecting statin use.

Suggested strategies to managing SAMS include re-challenging and switching statins, taking an alternative statin with different pharmacokinetic characteristics, using lower than indicated intensity of statin therapy, making healthy lifestyle changes and adding a non-statin agent to prevent ASCVD events. They also propose using nutraceuticals to lower LDL-C in patients with SAMS or aversion to statins.

The researchers conclude that the most essential approach to muscle complaints is to communicate and engage the patients to overcome their concerns. They found that most individuals who claimed to be "intolerant" to two or more statins in randomized, controlled, crossover trials could tolerate statin therapy upon re-challenge.

"When a patient presents with SAMS, health care providers should verify that the patient truly cannot tolerate statin therapy," the researchers write. "These efforts involve evaluation of symptoms after drug withdrawal and assessment of symptoms upon reinitiation with an alternative statin or lower doses of the same or a different statin."